Guide wire element for positioning vascular closure devices and methods for use

ABSTRACT

An apparatus for sealing a passage through tissue includes a threaded plug detachably carried on a distal end of a delivery device. A guide wire element is receivable through the lumens extending through the plug and delivery device that includes expandable wings adjacent its distal end, and markers adjacent its proximal end. During use, the guide wire element is advanced through a passage through tissue into a blood vessel. The wings on the distal end are expanded within the vessel, and the guide wire element withdrawn until the wings contact a wall of the vessel. The plug is threaded into the passage over the guide wire element until the markers appear from the delivery device, and released from the delivery device, thereby deploying the plug member adjacent the vessel to seal the passage.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of application Ser.No. 09/866,548, filed May 25, 2001, which is a continuation-in-part ofapplication Ser. No. 09/738,431, filed Dec. 14, 2000, the disclosures ofwhich are expressly incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present invention relates generally to apparatus and methodsfor sealing or closing passages through tissue, and more particularly todevices for sealing punctures or other openings communicating with bodylumens, such as blood vessels, and to apparatus and methods fordelivering such devices.

BACKGROUND

[0003] Catheterization and interventional procedures, such asangioplasty or stenting, generally are performed by inserting a hollowneedle through a patient's skin and any intervening tissue into thevascular system. A guide wire may then be passed through the needlelumen into the patient's blood vessel accessed by the needle. The needlemay be removed, and an introducer sheath may be advanced over the guidewire into the vessel, e.g., in conjunction with or subsequent to adilator. A catheter or other device may then be advanced through a lumenof the introducer sheath and over the guide wire into a position forperforming a medical procedure. Thus, the introducer sheath mayfacilitate introducing various devices into the vessel, while minimizingtrauma to the vessel wall and/or minimizing blood loss during aprocedure.

[0004] Upon completing the procedure, the devices and introducer sheathmay be removed, leaving a puncture site in the vessel wall. Externalpressure may be applied to the puncture site until clotting and woundsealing occur. This procedure, however, may be time consuming andexpensive, requiring as much as an hour of a physician's or nurse'stime. It is also uncomfortable for the patient, and requires that thepatient remain immobilized in the operating room, catheter lab, orholding area. In addition, a risk of hematoma exists from bleedingbefore hemostasis occurs.

[0005] Various apparatus have been suggested for percutaneously sealinga vascular puncture by occluding the puncture site. For example, U.S.Pat. Nos. 5,192,302 and 5,222,974, issued to Kensey et al., describe theuse of a biodegradable plug that may be delivered through an introducersheath into a puncture site. When deployed, the plug may seal the vesseland provide hemostasis. Such devices, however, may be difficult toposition properly with respect to the vessel, which may be particularlysignificant since it is generally undesirable to expose the plugmaterial, e.g., collagen, within the bloodstream, where it may floatdownstream and risk causing an embolism.

[0006] Another technique has been suggested that involves percutaneouslysuturing the puncture site, such as that disclosed in U.S. Pat. No.5,304,184, issued to Hathaway et al. Percutaneous suturing devices,however, may require significant skill by the user, and may bemechanically complex and expensive to manufacture.

[0007] Staples and surgical clips have also been suggested for closingwounds or other openings in tissue. For example, U.S. Pat. Nos.5,007,921 and 5,026,390, issued to Brown, disclose staples that may beused to close a wound or incision. In one embodiment, an “S”-shapedstaple is disclosed that includes barbs that may be engaged into tissueon either side of the wound. In another embodiment, a ring-shaped stapleis disclosed that includes barbs that project from the ring. Thesestaples, however, have a large cross-sectional profile and therefore maynot be easy to deliver through a percutaneous site to close an openingin a vessel wall.

[0008] In addition, skin seals have been proposed that may be threadedinto an opening in skin. For example, U.S. Pat. No. 5,645,565, issued toRudd et al., discloses a surgical plug that may be screwed into apuncture to seal the puncture. The surgical plug includes an enlargedcap and a threaded shaft that extends from the cap. During an endoscopicprocedure, the plug may be threaded into an opening through skin untilthe cap engages the surface of the skin. The plug is intended to sealthe opening communicating with a body cavity to prevent insufflationfluid from leaking from the cavity. Such plugs, however, may only beused at the surface of the skin, and may not be introduced throughtissue, for example, to seal an opening in the wall of a blood vessel orother subcutaneous region.

[0009] Accordingly, devices for sealing punctures or other passagesthrough tissue, e.g., an opening into a blood vessel, would beconsidered useful.

SUMMARY OF THE INVENTION

[0010] The present invention is directed to apparatus and methods forsealing or closing passages through tissue, such as puncturescommunicating with blood vessels or other body lumens.

[0011] In accordance with one aspect of the present invention, a devicefor sealing a passage through tissue is provided that includes a body orplug member including a proximal end and a distal end. The bodygenerally includes a lumen extending between the proximal and distalends, the lumen including a reduced cross-sectional region, e.g., atapered distal region. The body may include elements, e.g., a helicalthread pattern, flutes, ribs, and/or ridges, on an outer surface thereofthat extend at least partially between the proximal and distal ends.Such elements may facilitate advancing the body into a passage throughtissue and/or sealing the passage. Alternatively, the outer surface maybe substantially smooth.

[0012] A sealing member, e.g., having a generally annular shape, isslidably disposed within the lumen of the body that includes a lumenextending between proximal and distal ends thereof, and a plurality ofshoulders disposed about the lumen of the sealing member. The shouldersmay be deflectable towards one another when the sealing member is movedat least partially into the reduced cross-sectional region, thereby atleast partially sealing the lumen of the sealing member and/or the lumenof the body.

[0013] The body and/or the sealing member may be formed frombiocompatible and/or bioabsorbable material. Preferably, both the bodyand the sealing member are bioabsorbable, thereby providing a plugmember that may be delivered into a body passage to substantially sealand/or close the passage, the plug member remaining within the passageuntil it is absorbed by surrounding tissue.

[0014] In accordance with another aspect of the present invention, anapparatus is provided for sealing a passage through tissue, e.g., todeliver a plug member. The apparatus may include a plug member, such asthat described above, e.g., including a body having a lumen extendingbetween proximal and distal ends thereof. The lumen may include areduced cross-sectional region, e.g., a tapered distal region. A sealingmember may be slidably disposed within the lumen of the body that iscompressible when directed into the reduced cross-sectional region forat least partially sealing the lumen of the sealing member and/or thelumen of the body. For example, the sealing member may include aplurality of shoulders disposed about a lumen of the sealing member thatare deflectable towards one another.

[0015] In addition, the apparatus may include a handle device includingan elongate outer member and an elongate inner member having proximaland distal ends defining a longitudinal axis therebetween. The distalend of the outer member may be detachably coupled to the proximal end ofthe body. In addition or alternatively, the distal end of the innermember may be slidable axially within the lumen of the body for at leastpartially moving the sealing member into the reduced cross-sectionalregion of the lumen in the body, thereby deflecting the shoulderstowards one another or otherwise compressing the sealing member to atleast partially seal the lumen in the body and/or the lumen in thesealing member.

[0016] Optionally, the proximal end of the body may include a proximalopening including a major axis and a minor axis, e.g., an ellipticalopening, and the outer member may include opposing elements on itsdistal end. The opposing elements may be movable away from one anotherto define a major axis that substantially engages the proximal openingto secure the body to the distal end of the outer member.

[0017] To create this engagement, the inner member may include one ormore flared regions on its distal end. The inner member may be movableproximally relative to the outer member such that the one or more flaredregions slidably engage the opposing elements to move the opposingelements away from one another to engage the walls defining the proximalopening in the body. In addition, the inner member may be movabledistally relative to the outer member for disengaging the opposingelements on the outer member from the proximal end of the body. Thesealing member may be directed at least partially into the reducedcross-sectional region of the lumen in the body as the inner member ismoved distally, thereby deflecting the shoulders on the sealing membertowards one another or otherwise compressing the sealing member to atleast partially seal the lumen in the body and/or the lumen in thesealing member.

[0018] In accordance with still another aspect of the present invention,a method is provided for sealing a passage through tissue from apatient's skin to a body lumen. Initially, a guide wire element isprovided that extends from the patient's skin through the passage andinto the body lumen.

[0019] A plug member, e.g., a generally annular body, may be advancedinto the passage over the guide wire element, the body including a lumenthrough which the guide wire element is inserted as the body is advancedinto the passage. The body may include a sealing member therein at leastpartially surrounding the guide wire element. The sealing member mayinclude a lumen concentric with the lumen in the body such that theguide wire element may be inserted through both lumens.

[0020] In a preferred embodiment, the body includes an external threadpattern, and the body may be advanced into the passage by rotating thebody, thereby threading the body into the passage. A handle device maybe coupled to the body such that the handle device may be rotated,thereby threading the body into the passage. Once a desired location isreached, the body may be deployed from the handle device.

[0021] While or before the body is deployed, the sealing member may bedirected into a reduced cross-sectional region of the lumen in the body,thereby compressing the sealing member to at least partially seal thelumen. Preferably, a plurality of shoulders on the sealing member aredeflected towards one another as the sealing member is directed into thereduced cross-sectional region to at least partially seal the lumen. Allor a portion of the guide wire element may be withdrawn from thepassage, i.e., through the body and/or handle device, before compressingthe sealing member into the reduced cross-sectional region. For example,in one method, the entire guide wire element may be withdrawn before thesealing member is compressed to seal the lumen. Alternatively, at leasta portion of the guide wire element may remain within the sealing memberas it compressed, as described further below.

[0022] In accordance with another aspect of the present invention, aguide wire or positioning device is provided that includes one or morewires including a proximal end and one or more lateral elements on adistal end thereof. The guide wire element may include one or morevisual markers on the proximal end thereof, the markers being located apredetermined distance from the lateral elements. Preferably, thepredetermined distance corresponds to a length of the delivery deviceand the plug member carried thereby for providing a visual indication ofthe relative location of the lateral elements and the distal end of theplug member when the visual marker is visible beyond the proximal end ofthe delivery device.

[0023] In one embodiment, the lateral elements may include one or moreexpandable wings, and preferably, at least two opposing wings, that maybe actuable from the proximal end of the guide wire element forselectively expanding and collapsing the wings. In a preferredembodiment, the guide wire element includes an elongate outer wireincluding proximal and distal ends, one or more wings or expandablepositioning elements adjacent the distal end, one or more wings orexpandable actuator elements adjacent the proximal end, and anintermediate region extending between the positioning and actuatorelements.

[0024] The guide wire element also includes an elongate inner wireincluding proximal and distal ends that are fixed relative to theproximal and distal ends of the outer wire. The intermediate region ofthe outer wire may be movable axially relative to the inner wire forexpanding and collapsing the positioning and actuator elements.Preferably, the positioning elements are collapsed when the actuatorelements are expanded. The positioning elements may be expanded bycompressing the actuator elements inwardly, thereby directing theintermediate region of the outer wire towards the distal end, andcausing the positioning elements to buckle or otherwise expand radiallyoutwardly. The positioning elements may be biased to the collapsedconfiguration, e.g., such that when a constraining force on the actuatorelements is removed, the positioning elements may automatically returntowards the collapsed configuration.

[0025] Alternatively, the proximal end of the inner wire may be movableaxially relative to the outer wire. For example, a handle may extendfrom the proximal end of the inner wire, such that the handle may bedirected proximally to buckle or otherwise expand the positioningelements. In addition or alternatively, a spring element may be coupledbetween the inner and outer wires for biasing the positioning andactuator elements towards one of the collapsed and expandedconfigurations. Preferably, the spring biases the positioning elementsto collapse towards the collapsed configuration when the handle isreleased.

[0026] In accordance with yet another aspect of the present invention,an apparatus is provided for sealing a passage through tissue in a bodythat includes an elongate delivery device including a lumen extendingbetween proximal and distal ends thereof, and defining a longitudinalaxis. A plug member, such as that described above, may be detachablycarried by the distal end of the delivery device that includes a lumencommunicating with the lumen of the delivery device.

[0027] The apparatus may also include a guide wire element including aproximal end receivable through the lumens in the plug member and thedelivery device. The guide wire element may include one or more lateralelements on a distal end thereof, for example, one or more expandablewings or legs, as described above. The guide wire element may includeone or more visual markers on the proximal end thereof that are locateda predetermined distance from the lateral elements.

[0028] In one embodiment, the lateral elements may include one or moreexpandable wings, and preferably, at least two opposing wings, that maybe actuable from the proximal end of the guide wire element forselectively expanding and collapsing the wings, as described above. Inanother embodiment, the lateral elements may include legs that arebiased to extend transversely relative to a longitudinal axis of theguide wire element, but may be deflected to a collapsed configuration tofacilitate advancing the guide wire element into a passage throughtissue.

[0029] In accordance with still another aspect of the present invention,a method is provided for sealing a passage through tissue from apatient's skin to a body lumen. A distal end of a guide wire element maybe advanced from the patient's skin through the passage and into a bodylumen, e.g., through a percutaneous puncture communicating with a bloodvessel. One or more lateral elements on the distal end of the guide wireelement may be expanded within the body lumen, and the guide wireelement may be at least partially withdrawn from the body lumen untilthe one or more lateral elements contact a wall of the body lumen.

[0030] A proximal end of the guide wire element may be inserted into alumen of a plug member, and the plug member may be advanced into thepassage over the guide wire element. In a preferred embodiment, the plugmember may include an external thread pattern, and the plug member maybe advanced by rotating the plug member, thereby threading the plugmember into the passage.

[0031] The plug member may be advanced into the passage until the plugmember is disposed adjacent to the one or more lateral elements. Theplug member may be carried on a distal end of a delivery device, and theplug member may be released from the distal end of the delivery deviceafter the plug member is advanced into the passage. For example, theguide wire element may include a marker on a proximal portion thereofthat is located a predetermined distance from the one or more lateralelements. The plug member may be released from the delivery device whenthe marker appears from a proximal end of the delivery device, therebydeploying the plug member adjacent to the one or more lateral elements.Alternatively, the plug member may be released from the delivery deviceafter the plug member contacts the one or more lateral elements.

[0032] A sealing member within the lumen in the plug member may bedirected into a reduced cross-sectional region of the lumen, thereby atleast partially sealing the lumen. Preferably, the sealing member iscompressed before or as the plug member is deployed from the deliverydevice.

[0033] At least a portion of the guide wire element may be withdrawnfrom the passage, i.e., through the lumen of the plug member. Forexample, the one or more lateral elements may be collapsed, and theguide wire element may be withdrawn through the lumen of the plug memberand removed entirely from the passage. Preferably, the guide wireelement is withdrawn before the sealing member is compressed to seal thelumen in the plug member.

[0034] In accordance with another aspect of the present invention, adevice for sealing a passage through tissue is provided that includes aplug member, such as those described above, including a lumen extendingbetween proximal and distal ends thereof, and a guide wire elementincluding a proximal end receivable through the lumen in the plugmember. The guide wire element may include one or more lateral elementson a distal portion thereof, the one or more lateral elements beingdeflectable from an expanded configuration towards a collapsedconfiguration optionally, the guide wire element may be tubularincluding a bleed back lumen extending between the proximal and distalends.

[0035] The distal portion of the guide wire element may be severablefrom a proximal portion of the guide wire element. The body and at leastthe distal portion of the guide wire element may be formed frombiocompatible material, and preferably from bioabsorbable material, suchthat the body and the distal portion of the guide wire element may bereleased within a passage through tissue.

[0036] In a preferred embodiment, the lateral elements include a pair ofopposing legs extending away from one another in the expandedconfiguration. More preferably, the opposing legs define a cross-sectionthat is larger than the lumen in the plug member in the expandedconfiguration.

[0037] In accordance with yet another aspect of the present invention,an apparatus is provided for sealing a passage through tissue in a bodythat includes an elongate delivery device including a lumen extendingbetween proximal and distal ends thereof, and defining a longitudinalaxis. A plug member is detachably carried by the distal end of thedelivery device that includes a lumen communicating with the lumen ofthe delivery device.

[0038] A guide wire element is also provided that includes a proximalend receivable through the lumens in the plug member and the deliverydevice. The guide wire element includes one or more lateral elements ona distal portion thereof, the one or more lateral elements beingdeflectable from an expanded configuration towards a collapsedconfiguration, the distal portion being severable from a proximalportion of the guide wire element. Preferably, the plug member and thedistal portion of the guide wire element are formed from at leastpartially from bioabsorbable material.

[0039] The guide wire element may include a visual marker on theproximal end thereof, the marker being located a predetermined distancefrom the one or more lateral elements. The predetermined distance maycorrespond to a length of the delivery device and the plug membercarried thereby for providing a visual indication of the relativelocation of the one or more lateral elements and the distal end of theplug member when the visual marker is visible beyond the proximal end ofthe delivery device. In addition or alternatively, the guide wireelement may include a bleed back lumen extending between its proximaland distal ends.

[0040] In addition, the plug member may include a sealing memberslidably disposed within the lumen of the plug member. In oneembodiment, the sealing member may include a plurality of shouldersdisposed about a lumen of the sealing member, the shoulders beingdeflectable towards one another for at least partially sealing the lumenof the sealing member.

[0041] The sealing member may be movable into a reduced cross-sectionalregion of the lumen in the plug member for at least partially sealingthe lumen in the plug member. The sealing member may also engage aportion of the distal portion of the guide wire element when the sealingmember is moved into the reduced cross-sectional region of the lumen inthe plug member, thereby substantially securing the distal portion ofthe guide wire element to the plug member. If the guide wire elementincludes a bleed back lumen, the sealing member may compress the guidewire element to seal the bleed back lumen when the sealing member iscompressed in the reduced cross-sectional region.

[0042] In addition, the apparatus may include a cutting element forsevering the distal portion of the guide wire element from a proximalportion thereof.

[0043] In accordance with still another aspect of the present invention,a method is provided for sealing a passage through tissue from apatient's skin to a body lumen. A distal end of a guide wire element maybe advanced from the patient's skin through the passage and into thebody lumen, e.g., through a percutaneous puncture into a blood vessel.The guide wire element may include one or more lateral elements on thedistal end of the guide wire element, which may be collapsed inwardly asthe guide wire element is advanced through tissue, e.g., to reduce theguide wire element's profile and facilitate advancement through thepassage. Optionally, the guide wire element may include a bleed backlumen that extends between its proximal and distal ends, providing avisual indicator when the distal end has entered the body lumen.

[0044] Once the distal end enters the body lumen, the lateral elementsmay automatically return to a transverse, expanded configuration. Theguide wire element may be partially withdrawn from the body lumen untilthe one or more lateral elements contact a wall of the body lumen,thereby providing a tactile indication that the distal end of the guidewire element is disposed adjacent the wall of the body lumen.

[0045] A proximal end of the guide wire element may be inserted into alumen of a plug member, and the plug member may be advanced into thepassage over the guide wire element. In one embodiment, the plug membermay include an external thread pattern, and may be advanced by rotatingthe plug member, thereby threading the plug member through the passage.The plug member may be advanced into the passage until the plug memberis disposed adjacent to the one or more lateral elements.

[0046] A distal portion of the guide wire element may be securedrelative to the plug member with the one or more lateral elementsdisposed substantially against the wall of the body lumen. For example,the plug member may include a sealing member therein at least partiallysurrounding the guide wire element. The sealing member may be directedinto a reduced cross-sectional region of the lumen, thereby securing thedistal portion of the guide wire element to the plug member. If theguide wire element includes a bleed back lumen, the sealing member mayalso compress the guide wire element to substantially seal the bleedback lumen. In addition, the sealing member may at least partially sealthe lumen in the plug member as the sealing member is directed into thereduced cross-sectional region of the lumen.

[0047] A proximal portion of the guide wire element may be removed fromthe passage, leaving the plug member to substantially seal and/or closethe passage, with the distal portion of the guide wire element securedto the plug member. For example, a cutting element may be introducedinto the passage to cut or otherwise sever the guide wire element at alocation proximal to the plug member, whereupon the proximal portion maybe withdrawn from the passage.

[0048] Other objects and features of the present invention will becomeapparent from consideration of the following description taken inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0049]FIG. 1A is a perspective view of a plug member, in accordance withthe present invention.

[0050]FIG. 1B is an end view of the proximal end of the plug member ofFIG. 1A.

[0051]FIG. 1C is a cross-sectional side view of the plug member of FIG.1A, including a collet disposed therein, in accordance with the presentinvention.

[0052]FIG. 2A is a side view of a first embodiment of the collet shownin FIG. 1C.

[0053]FIGS. 2B and 2C are end views of a proximal end of the collet ofFIG. 2A in open and closed positions, respectively.

[0054]FIG. 2D is a cross-sectional side view of the collet of FIG. 2A.

[0055]FIG. 3 is a perspective view of an apparatus for delivering a plugmember, in accordance with the present invention.

[0056] FIGS. 4A-4D are cross-sectional views of the distal end of theapparatus of FIG. 3, during various stages of deploying the plug member.

[0057]FIG. 4E is a cross-sectional view of the distal end of theapparatus of FIGS. 3 and 4B, taken along line 4E-4E.

[0058]FIGS. 5A and 5B are cross-sectional views of a guide wire elementof the apparatus of FIG. 3, with expandable wings thereon in collapsedand expanded configurations, respectively.

[0059]FIGS. 6A and 6B are side views of an alternative embodiment of aguide wire element having a spring element, in accordance with thepresent invention.

[0060] FIGS. 7A-7D are side views of a plug member and handle devicebeing advanced over a guide wire element, and showing positioningmarkers on the guide wire element.

[0061] FIGS. 8A-8E are cross-sectional side views of a passagecommunicating with a blood vessel, showing a method for delivering aplug member to seal the passage.

[0062]FIGS. 9A and 9B are side views of yet another embodiment of aguide wire element, in accordance with the present invention.

[0063] FIGS. 10A-10E are cross-sectional side views of a passagecommunicating with a blood vessel, showing a method for delivering aplug member into the passage using the guide wire element of FIGS. 9Aand 9B.

[0064]FIG. 11A is a cross-sectional view of an alternative embodiment ofan apparatus for delivering a plug member, in accordance with thepresent invention.

[0065]FIG. 11B is a cross-sectional view of yet another alternativeembodiment of an apparatus for delivering a plug member, in accordancewith the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0066] Turning now to the drawings, FIGS. 1A, 1B, and 1C show a firstpreferred embodiment of a plug member 12 for sealing a passage throughtissue (not shown), in accordance with the present invention. The plugmember 12 is a substantially rigid body, preferably having a generallycylindrical shape, including a proximal end 20, a distal end 22, and anouter surface 30. The plug member 12 includes a lumen 24 that extendsbetween a proximal opening 26 and a distal opening or port 28.

[0067] The plug member 12 may be formed from a biocompatible material,e.g., a plastic, such as polyethylene or polyester. Preferably, the plugmember 12 is formed at least partially (and more preferably entirely)from bioabsorbable material, such as collagen, polyglycolic acids(PGA's), polyactides (PLA's), and the like, which may be at leastpartially absorbed by the patient's body over time. Alternatively, theplug member 12 may be a semi-rigid or flexible body or may have asubstantially flexible distal tip (not shown), e.g., to facilitatesubstantially atraumatically inserting the plug member 12 into apassage.

[0068] The plug member 12 may have a substantially uniform outercross-section defined by outer surface 30 or may be tapered along itslength. In addition, the distal end 22 may be rounded to facilitateadvancing the plug member 12 into a passage through tissue. In apreferred embodiment, the plug member 12 has a length of not more thanabout ten millimeters (10 mm), and more preferably between about one andten millimeters (1-10 mm). The plug member 12 also preferably has adiameter of between about one and twenty millimeters (1-20 mm).Preferably, the length and diameter have a ratio that is not more thanabout two-to-one.

[0069] The plug member 12 generally includes a helical thread pattern18, including one or more helical threads, that extends at leastpartially between its proximal and distal ends 20, 22. Preferably, thethread pattern 18 extends completely to the distal-end 22 of the plugmember 12, and may be tapered at the distal end 22 to facilitateintroduction into a passage through tissue (not shown). The helicalthread 18 is preferably substantially rigid and may have a substantiallysquare cross-section to facilitate sealing of a passage into which theplug member 12 is threaded. The helical thread 18 may be substantiallycontinuous, i.e., extending helically around the outer surface 30 or,alternatively, may be intermittent (not shown). Alternatively, otherfeatures may be provided on the outer surface 30 instead of or inaddition to the helical thread 30, e.g., flutes, ribs, ridges, and thelike (not shown).

[0070] In a preferred embodiment, the helical thread 18 is integrallyformed on the outer surface 30 of the plug member 12. For example, theplug member 12 and thread 18 may both be formed as a unitary structure,e.g., by injection molding. Alternatively, the threads may be cut orotherwise formed in the outer surface 30 of the plug member 12 after theplug member 12 is formed. In a further alternative, the thread patternmay be eliminated, thereby providing a substantially smooth outersurface (not shown).

[0071] The lumen 24 extending through the plug member 12 may include aproximal region 21 and a tapered distal region 23, the distal region 23tapering inwardly away from the proximal region 21 towards the distalopening 28. Thus, the distal region 23 near the proximal region 21 maydefine a larger cross-section lumen 24 than the distal region 23 nearthe distal opening 28.

[0072] The proximal region 21 of the lumen 24 may be elliptical incross-section, while the outer surface 30 of the plug member 12 may besubstantially round. Thus, the proximal region 21 of the lumen 24 mayinclude a major axis A₁ and a minor axis a₁ (best seen in FIG. 1B). Themajor and minor axes A₁, a₁, of the proximal region 21 of the lumen 24,together with corresponding axes on a handle device 14 (not shown, see,e.g., FIGS. 3-4B), may provide a locking mechanism between the plugmember 12 and the handle device 14, as described further below.

[0073] A collet or sealing member 60 may be disposed within the lumen 24of the plug member 12 that may be movable axially therein, e.g., fromwithin the proximal region 21 towards the distal end 22 of the plugmember 12. The collet 60 may be a generally annular body including aproximal end 61, a distal end 62, and a lumen 64 (best seen in FIGS.2A-2D) extending between the proximal and distal ends 60, 62. When thecollet 60 is disposed within the plug member 12, the lumen 64 of thecollet 60 may be in fluid communication with the lumen 24 of the plugmember 12. Also, when placed within the lumen 24 of the plug member 12,the collet 60 may be sufficiently flexible to generally conform to theshape of the lumen 24. For example, if the lumen 24 of the plug member12 is tapered along its length and/or has an elliptical cross-section,as shown in FIGS. 1A-1C, the collet 60, when placed within lumen 24, mayalso become tapered along its length and/or assume an ellipticalcross-section.

[0074] Alternatively, other sealing members may be provided instead ofthe collet 60. For example, an annular member, e.g., a helically woundsheet of material or a solid annular body, may be provided that iscompressible (not shown). Exemplary embodiments of a sealing member thatmay be incorporated into the plug member 12 are disclosed in applicationSer. No. 09/866,548, filed May 25, 2001, incorporated by referenceherein.

[0075] Turning to FIGS. 2A-2D, a preferred embodiment of the collet 60is shown that includes a proximal end 61 and a distal end 62 defining alumen 64 therebetween. The collet 60 also has a proximal opening 66 anda distal opening 68 that are located at the proximal and distal ends 61,62, respectively, and communicating with the lumen 64, respectively. Aplurality of radial slots 65 may be formed in the proximal end 61 thatare oriented inwardly towards the lumen 64, thereby defining a pluralityof flexible or semi-rigid shoulders 63 disposed circumferentially aboutthe lumen 64.

[0076] The collet 60 may be formed from a biocompatible material, e.g.,a plastic, such as polyethylene or polyester. Preferably, the collet 60is formed at least partially (and more preferably entirely) frombioabsorbable material, such as collagen, polyglycolic acids (PGA's),polyactides (PLA's), and the like, similar to the plug member 12. Inaddition or alternatively, the collet 60 may be formed from a materialthat expands when exposed to fluids, e.g., collagen and/or an expandablefoam. Exemplary materials that may be appropriate for use in the collet60 and/or the plug member 12 are disclosed in U.S. Pat. No. 6,224,630,the disclosure of which is expressly incorporated herein by reference.In addition, all or a portion of the collet 60 may be coated with atherapeutic substance, such as a thrombogenic material, e.g., along thelumen 64.

[0077] Preferably, the collet 60 is more flexible than the plug member12, thereby enabling the collet 60 to conform substantially to thecontours of the lumen 24 of the plug member 12. The collet 60 may adopta circular cross-section when in a relaxed state (free from externalconstraints or forces), as best seen in FIG. 2B. Once placed within thelumen 24 of the plug member 12, however, the collet 60 may conformsubstantially to the contours of the lumen 24. For example, when placedwithin a lumen 24 that is elliptical in cross-section, as shown in FIG.1B, the collet 60 may also become substantially elliptical incross-section.

[0078] As best seen in FIG. 2B, the shoulders 63 are arranged around thelumen 64 and initially define an expanded or open position. In the openposition, the slots 65 space apart adjacent shoulders 63 and the inneredges 67 of the shoulders 63 define a relatively open proximal opening66. Therefore, in the open position, fluid is able to flow relativelyfreely through the proximal opening 66 and the lumen 64.

[0079] Turning to FIG. 2C, the shoulders 63 are sufficiently flexiblethat they may be deflected inwardly towards one another, therebydefining a closed position. In the closed position, the inner edges 67move towards one another such that the proximal opening 66 issubstantially smaller, and may be entirely closed. In the closedposition, fluid flow through the proximal opening 66 is restricted, andmay be substantially completely obstructed, compared to the openposition. Thus, the collet 60 may be compressed to substantially sealthe lumen 24 from fluid flow therethrough when the collet 60 is in theclosed position.

[0080] The shoulders 63 of the collet 60 may be deflected from the openposition towards the closed position by exerting an inward force on theshoulders 63. For example, with the collet 63 disposed within the plugmember 12, as shown in FIG. 1C, a distal force “F” may be applied to theproximal end 61 of the collet 60. This may cause the collet 60 to enterand move distally into the tapered region 23 of the lumen 24, therebysubjecting the shoulders 63 to an inward force that causes the shoulders63 to deflect inwardly towards the closed position (not shown in FIG.1C, see, e.g., FIG. 2C).

[0081] Turning to FIGS. 3 and 4A-4E, the plug member 12 may beincorporated into an apparatus 10 for sealing a passage through tissue.Generally, the apparatus 10 includes a handle or delivery device 14 forcarrying the plug member 12 and/or a guide wire element 16 forpositioning the plug member 12 during delivery. The handle device 14generally includes an tubular outer member 80 and an elongate innermember 70 slidably received in the outer member 80. The components ofthe handle device 14 may be formed from conventional biocompatiblematerials, e.g., plastic, such as polyethylene or polyester, and/ormetal, such as stainless steel. The handle device 14 preferably has across-section that is generally smaller than a cross-section of the plugmember 12, e.g., to minimize dilation of a passage into which theapparatus 10 is inserted.

[0082] With particular reference to FIGS. 4A-4E, the inner member 70 maybe substantially rigid, and preferably is a tubular body including alumen 74 (best seen in FIG. 4E) extending between a proximal end (notshown) and a distal end 76 of the inner member 70. As best seen in FIGS.4A-4C, the distal end 76 of the inner member 70 preferably includes oneor more flared regions that extend radially outwardly. The flared regionmay be a substantially continuous flared ridge 77 including a rampedsurface 77 a extending around a circumference of the distal end 76 andhaving a cross-section that is larger than the balance of the innermember 70. The flared ridge 77 may have an elliptical shape, as shown inFIG. 4E, although alternatively, the flared ridge may have asubstantially circular shape (not shown). In a further alternative, thedistal end 76 of the inner member 70 may include a plurality of ramps(not shown) extending from an outer surface of the inner member 70,e.g., in pairs opposite one another about the circumference of the innermember 70.

[0083] Returning to FIGS. 3 and 4A-4E, the outer member 80 may be asemi-rigid or flexible tubular body including a proximal end 81 (bestseen in FIG. 3), a distal end 86, and a lumen 84 extending between theproximal and distal ends 80, 86. As shown in FIGS. 4A-4C, the outermember 80 may also include a plurality of slots 88 that extendproximally from the distal end 86 a relatively short distance (comparedto a length of the outer member 80). Preferably, as best seen in FIG.4E, a pair of opposing slots 88 are provided that divide the distal end86 into opposing halves 89. The slots 88 enable the opposing halves 89to expand or otherwise move away from one another to increase thecross-section of the distal end 86, as explained further below.

[0084] Turning to FIG. 3, a handle 42 is attached to or otherwiseextends from the proximal end 81 of the outer member 80. An actuator,e.g., button 43, extends into the handle 42 that is coupled to theproximal end of the inner member 70 (not shown in FIG. 3) slidablyreceived in the outer member 80. Axial movement of the inner member 70relative to the outer member 80 may be limited, e.g., by the button 42and/or the flared ridge 77.

[0085] For example, as shown in FIG. 4B, the inner member 70 may bepositioned in a first or proximal position such that the flared ridge 77is disposed at least partially within the distal end 86 of the outermember 80, causing the opposing halves 89 to be expanded outwardly awayfrom one another, and thereby increasing a major axis dimension B₁ ofthe outer member 80 (shown in FIG. 4E). By depressing the button 43, theinner member 70 may be directed distally relative to the outer member80, e.g., to advance the flared ridge 77 out of the distal end 86 of theouter member 80, as shown in FIG. 4C. The distal end 86 of the outermember 80 may simply be relaxed when the flared ridge 77 is removed ormay be sufficiently resilient that the opposing halves 89 return atleast partially towards one another.

[0086] This expansion of the distal end of the outer member 80 may beused to substantially secure the plug member 12 to the handle device.14.Turning to FIG. 4A, with the flared ridge 77 outside the distal end 86of the outer member 80, the distal end 81 of the outer member 80 may beinserted into the proximal end 20 of the plug member 12. If the plugmember 12 includes a lumen 24 with an elliptical shaped proximal region,the slots 88 on the outer member 80 are preferably aligned with theminor axis a₁ of the proximal region 21, as best seen in FIG. 4E. Theinner member 70 may then be directed proximally such that the rampedsurface 77 a of the flared ridge 77 slidably engages and, consequently,expands the opposing halves 89 of the outer member 80 into engagementwith the plug member 12. The major axis B₁ of the outer member 80 mayincrease substantially to the major axis A₁ of the proximal region 21 ofthe lumen 24, i.e., until the opposing halves 89 frictionally engage theplug member 12. Preferably, this frictional engagement is sufficientlystrong that the plug member 12 is substantially fixed relative to theouter member 80. Consequently, any rotational force applied to the outermember 80, e.g., to the handle 42, may be translated to the plug member12 without allowing the plug member 12 to slip substantially relative tothe outer member 80.

[0087] During delivery of the plug member 12 to close a passage throughtissue, as explained further below, the handle device 14 may be used todeploy the plug member 12 from the outer member 80 and/or to compressthe collet 60 within the plug member 12 to substantially seal the lumen24 through the plug member 12. For example, the button 43 may bedepressed partially to advance the flared ridge 77 substantially out ofthe distal end 86 of the outer member 80 (as shown in FIG. 4A), therebyrelaxing the opposing halves 89 and substantially reducing thefrictional force securing the plug member 12 to the outer member 80.Depressing the button 43 may also direct the distal end 76 of the innermember 70 into contact with the proximal end 61 of the collet 60 withinthe lumen 24 in the plug member 12 and cause the collet 60 to movedistally within the lumen 24. Preferably, this causes the collet 60 totravel distally at least partially into or along the tapered distalregion 23 of the lumen 24 (as shown in FIG. 4C), thereby compressing theshoulders 63 towards one another to close the opening 66 therein, asexplained above. Once the collet 60 is forced into the distal region 23of the lumen 24, continued depression of the button 43 may cause theentire plug member 12 to be directed distally relative to the distal end86 of the outer member 80, e.g., to deploy the plug member 12 from thehandle device 14.

[0088] Turning to FIGS. 11A and 11B alternative embodiments of anapparatus 110, 210 are shown that include a handle device 114, 214 thatmay be used to deliver a plug member 112, 212, which are similar to theembodiment described above. Generally, as shown in FIG. 11A, the handledevice 114 includes a lumen 184 that extends between its proximal end(not shown) and its distal end 186, similar to the previous embodiment.Unlike the previous embodiment, the handle device 114 and the plugmember 112 include mating threads 123, 121. Preferably, the matingthreads 123, 121 extend in the same direction as the thread pattern 118on the plug member 112. Thus, the handle device 114 may be rotated in afirst direction to thread the plug member 112 through tissue, and in asecond direction to unthread the plug member 112 from the handle device114.

[0089] Turning to FIG. 11B in a further alternative, the plug member 212and handle device 214 may include cooperating connectors for releasablycoupling the plug member 212 to the distal end 286 of the handle device214. For example, the handle device 214 may include tabs 223 that may bereceived in pockets 224 in the plug member 212. Thus, as the handledevice 214 is directed distally, the plug member 212 may remain securedto the distal end 286. If the handle device 214 is directed proximally,the tabs 223 may be withdrawn from the pockets 224, thereby releasingthe plug member 212 from the handle device 214. Other exemplarycooperating connectors that may be incorporated into the apparatus 210are described in application Ser. No. 09/738,431, filed Dec. 14, 2000,which is expressly incorporated by reference herein.

[0090] Turning to FIGS. 5A and 5B the guide wire element 16 is generallya flexible or semi-rigid elongate member including one or moreexpandable elements thereon. The guide wire element 16 generallyincludes a tubular outer element or wire 44 and an elongate innerelement or wire 54 that are at least partially slidable relative to oneanother. The outer wire 44 may be formed from a flexible or semi-rigidmaterial, such as plastic, and generally includes a proximal end 45 anda distal end 46, e.g., having a “J” tip or other substantiallyatraumatic tip. The outer wire 44 includes a proximal actuator region 47and a distal expandable region 48 that are coupled to one another suchthat as one is radially expanded, the other is radially compressed, asexplained further below.

[0091] For example, as shown in FIG. 5A, in a first or collapsedconfiguration, the distal region 48 includes one or more wings 50 thatare collapsed, e.g., extending substantially parallel to thelongitudinal axis 17 of the guidewire element 16. Thus, the outer wire44 may have a substantially uniform cross-section distal to the actuatorregion 47. Preferably, the outer wire 44 defines an outer diameter thatis not more than about half to two millimeters (0.5-2.0 mm).

[0092] The wings 50 may be formed in the outer wire 44 by creating aplurality of longitudinal slots 51 in the wall of the outer wire 44.Living hinges or other bends 52 may be formed in the outer wire 44,e.g., by notching the wall or otherwise programming bends into the wallmaterial, as is known in the art. Similar wings 53 may be formed in theactuator region 47 that, in the collapsed configuration, may extendradially outwardly.

[0093] Turning to FIGS. 3 and 5B in a second or expanded configuration,the wings 50 on the distal region 48 extend radially outwardly and thewings 53 on the actuator region 47 are collapsed, e.g., extendingsubstantially parallel to the longitudinal axis 17. In a preferredembodiment, the distal region 48 includes two opposing wings 50, as bestseen in FIG. 3, although alternatively, the distal region 48 may includefour or more wings (not shown). Similarly, the actuator region 47 mayinclude any number of wings, such as the two wings 53 shown in FIG. 5A.

[0094] Referring again to FIGS. 5A and 5B the inner wire 54 may be solidor hollow, and may be formed from conventional guide wire materials,such as stainless steel or Nitinol, such that the guide wire element 16has sufficient column strength to resist buckling or kinking. The innerwire 54 includes a proximal portion 55 and a distal portion 56, both ofwhich may be at least partially received within the outer wire 44. Withthe proximal portion 55 of the inner wire 54 disposed proximal to theactuator region 47, the proximal portion 55 may be fixed relative to theouter wire 44. For example, the proximal portion 52 of the inner wire 54may be bonded to the inner wall of the outer wire 44, e.g., using anadhesive, sonic welding, melting, and the like. Similarly, the distalportion 56 of the inner wire 54 may be disposed distal to the distalregion 48 of the outer wire 44 and fixed, e.g., to the inner wall of theouter wire 44.

[0095] Thus, an intermediate region 57 of the outer wire 44 may befreely slidable relative to an intermediate region 58 of the inner wire54, while the respective proximal and distal ends remain fixed. Thisrelative fixation may facilitate directing the outer wire 44 between thecollapsed and expanded configurations. For example, as shown in FIG. 5A,the wings 53 on the actuator region 47 are expanded, while the wings 50on the distal region 48 are collapsed. By compressing the wings 53 onthe actuator region 47 inwardly, the intermediate region 57 of the outerwire 44 may be directed distally relative to the intermediate region 58of the inner wire 54. This causes the wings 53 on the distal region 48to buckle and expand until, when the wings 50 are collapsed, the wings53 are expanded, as shown in FIG. 5B.

[0096] In one embodiment, the outer wire 44 may be biased towards thecollapsed configuration. Thus, when an inwardly compressive force isremoved from the wings 53 on the actuator region 47, the wings 53 mayautomatically expand, thereby causing the wings 53 on the distal region48 to collapse. Alternatively, the intermediate region 57 of the outerwire 44 may be manually directed proximally, thereby collapsing thewings 50 and expanding the wings 53.

[0097] In a further alternative, shown in FIGS. 6A and 6B guide wireelement 16′ may include a spring element 144 for biasing the guide wireelement 16′ towards one of the collapsed and expanded configurations.The guide wire element 16′ shares common elements with guide wireelement 16, and therefore, for simplicity, the same reference numbershave been used to identify common elements. For example, similar to theprevious embodiment, the guide wire element 16′ includes outer and innerwires 44, 54, the outer wire 44 including proximal and distal regions47, 48 with wings 53, 50. Unlike the previous embodiment, the proximalportion 55 of the inner wire 54 is not fixed relative to the proximalend 45 of the outer wire 44, but is movable axially, preferably within apredetermined range.

[0098] The spring element 144 is coupled between the proximal portion 55of the inner wire 54 and the proximal end 45 of the outer wire 44, e.g.,to bias the outer wire 44 towards the collapsed configuration.Preferably, the spring element is an extension spring that is disposedconcentrically around the inner wire 54, thereby minimizing a profile ofthe guide wire element 16′. A handle 140 may be coupled to the proximalportion 55 of the inner wire 54 that extends proximally from theproximal end 45 of the outer wire 44. Thus, the handle 140 may be pulledproximally against the bias of the spring element 144, thereby directingthe inner wire 54 proximally relative to the outer wire 44 and causingthe wings 50 on the distal region 48 to expand towards the expandedconfiguration shown in FIG. 6B. When the handle 140 is released, thespring element 144 may retract the inner wire 54 distally, therebycollapsing the wings 50.

[0099] Optionally, cooperating elements or detents may be provided onthe handle 140 and/or inner wire 54, and on the outer wire 44 forlimiting movement of the inner wire 54. For example, once the handle 140has been pulled to expand the wings 50 on the distal region 48 of theouter wire 44, the handle 140 may be rotated about the longitudinal axis17 to engage detents (not shown) on the handle 140 and the outer wire 44to lock the guide wire element 16′ in the expanded configuration. Theguide wire element 16′ may then be manipulated, for example, to positiona plug member (not shown) within a passage through tissue (also notshown), as explained below. When it is desired to collapse the wings 50,the handle 140 may be pulled proximally and/or rotated back to disengagethe detents, and then released, whereupon the spring element 144 mayautomatically cause the wings 50 to collapse to the collapsedconfiguration.

[0100] In still a further alternative, an actuator housing (not shown)may be disposed around or otherwise coupled to the guide wire element 16for manipulating the wings 50 on the outer wire 44 between the collapsedand expanded configurations. For example, the actuator may includeelements (not shown) that engage the proximal end 45 and intermediateportion 57 of the outer wire 44. The elements may direct theintermediate portion 57 axially, i.e., distally and/or proximally,relative to the proximal end 45 for expanding and/or collapsing thewings 50. In yet another alternative, a tubular sleeve (not shown) maybe slidable over the guide wire element 16 to secure the wings 53 on theactuator region 47 when the outer wire 44 is in the expandedconfiguration.

[0101] Turning to FIGS. 7A-7D, the guide wire element 16 of FIGS. 5A and5B (or alternatively, the guide wire element 16′ of FIGS. 6A and 6B) mayinclude one or more visual indicators that facilitate positioning ahandle device 14 and plug member 12 along the guide wire element 16during delivery. For example, the outer wire 44 may include one or morecontrasting color areas located at predetermined distances from thedistal region 48. As best seen in FIG. 7A, the outer wire 44 may includea proximal color area 59 a a narrow color band 59 b, an intermediatecolor area 59 c, and a distal color area 59 d.

[0102] The color areas 59 a-59 d may include any color that is suitablefor casual observation by a user, with adjacent areas being differentcolors. For example, in one embodiment, the proximal color area 59 a andthe intermediate color area 59 c may be white, while the narrow colorband 59 b and the distal color area 59 d may be blue.

[0103] In addition or alternatively, the guide wire element 16 mayinclude a bleed back lumen (not shown). For example, a lumen may beprovided within the inner wire 54 that extends between its proximal anddistal ends. In a further alternative, a bleed back lumen (not shown)may be provided that extends through the plug member and/or handledevice.

[0104] Turning to FIGS. 7B-7D, the handle device 14 with the plug member12 carried thereby may be advanced over the guide wire element 16, e.g.,during delivery of the plug member 12. For example, the handle device 14may be advanced after the wings 50 have been expanded to the expandedconfiguration. As the handle device 14 is initially advanced over theguide wire element 16, the proximal color area 59 a becomes visiblebeyond the handle 42 of the handle device 14, as shown in FIG. 7B.

[0105] As the handle device 14 is advanced further, the narrow colorband 59 b may becomes visible, thereby providing a warning that the plugmember 12 is approaching the wings 50 on the distal region 48 of theouter wire 44, as shown in FIG. 7C. The narrow color band 59 b may beonly a few millimeters long, and the intermediate color band 59 c mayhave a predetermined length, e.g., ten millimeters (10 mm). Finally, asshown in FIG. 7D, as the handle device 14 is advanced still further, thedistal color area 59 d may appear. The intermediate color area 59 c maybe located a predetermined distance from the wings 50 on the outer wire44. Preferably, the predetermined distance corresponds to a length ofthe handle device 14 and plug member 12 such that when the distal colorarea 59 a begins to appear, it indicates that the distal end 22 of theplug member 12 is in close proximity to the wings 50.

[0106] Turning to FIGS. 8A-8E, an apparatus 10 in accordance with thepresent invention may be used to close and/or seal a passage throughtissue, for example, a puncture 92 extending from a patient's skin 94through intervening tissue 96 to a blood vessel 90. Preferably, theapparatus 10 is used to deliver a plug member 12 through the passage 92to a location in or adjacent to a wall 98 of the vessel 90 or other bodylumen. The passage 92 may be a conventional percutaneous puncturecreated to access a peripheral vessel, for example, a femoral, carotid,or radial artery.

[0107] An introducer (not shown) may be positioned through the passage92 into the vessel 90 in order to permit one or more instruments, e.g.,guide wires, catheters, and the like (also not shown), to be advancedinto the vessel 90 in order to perform a diagnostic and/or therapeuticprocedure at a location within the patient's body accessible from thevessel 90. Upon completing the procedure, any instruments may be removedfrom the introducer, and the introducer itself may be removed from thepassage 90.

[0108] Turning to FIG. 8A, with the outer wire 44 in the collapsedconfiguration, the guide wire element 16 may be introduced through thepassage 92 until the distal region 48 is located within the vessel 90,e.g., after the introducer (not shown) has been removed from the passage92. Alternatively, the introducer may remain in the passage 92, and theguide wire element 16 may be advanced through the introducer into thevessel 90, whereupon the introducer may be removed. If the guide wireelement 16 includes a bleed back lumen (not shown), as the distal region48 enters the vessel 90, blood may flow through the bleed back lumen andout the proximal end of the guide wire element 16 (not shown), therebyproviding a visual indication that the vessel 90 has been reached.

[0109] Turning to FIG. 8B once the distal region 48 of the guide wireelement 16 is positioned within the vessel 90, the wings 50 may beexpanded to the expanded configuration. For example, as explained above,the wings 53 on the actuator region 47 of the guide wire element 16 maybe compressed inwardly, thereby expanding the wings 50 on the distalregion 48. Alternatively, a handle (not shown) on the guide wire element16 may be pulled to expand the wings 50, also as explained above. Theguide wire element 16 may then be manipulated, e.g., pulled proximally,until the wings 50 on the distal region 48 contact the wall 98 of thevessel 90, as shown in FIG. 8C, thereby providing a tactile indicationof the location of the vessel 90.

[0110] The handle device 14 with the plug member 12 carried thereby maythen be advanced over the guide wire element 16 and into the passage 92.If the plug member 12 includes an external thread pattern 18, the handledevice 14 may be rotated to thread the plug member 12 through thepassage 92 towards the vessel 90. Alternatively, if the plug member 12includes a substantially smooth outer surface, it may be advancedaxially through the passage 92 without requiring rotation of the handlemember 14. With additional reference to FIG. 4B it will be appreciatedthat, as the handle device 14 is advanced over the guide wire element16, the guide wire element 16 may pass through the lumen 24 of the plugmember 12, and consequently, through the lumen 64 of the collet 61located within the plug member 12.

[0111] As explained above with reference to FIGS. 7A-7D, the guide wireelement 16 may include one or more visual indicators (not shown) locateda predetermined distance from the wings 50. When the visual indicatorsappear from the handle device 14, they indicate that the plug member 12is located at a predetermined location relative to the wall 98 of thevessel 90. Preferably, when the visual indicators appear, the plugmember 12 is located within or adjacent the wall 98 of the vessel 90, asshown in FIG. 8C.

[0112] Thus, the guide wire element 16 and the visual indicators thereonmay identify the location of the vessel 90 relative to the patient'sskin 94, and thereby indicate the depth to which the plug member 12should be advanced before being deployed from the handle device 14.Alternatively, if no visual indicators are provided, the wings 50 on theguide wire element 16 may provide a tactile indication when the plugmember 12 has reached a delivery location, e.g., when the distal end 22of the plug member 12 contacts the wings 50 on the guide wire element16. In a further alternative, the plug member 12 and/or handle device 14may include one or more bleed back lumens for indicating when the plugmember 12 has entered the vessel 90, in addition to or instead of thewings 50. Additional information on methods for delivering a plug member12 using bleed back indicators may be found in application Ser. No.09/866,548, filed May 25, 2001, incorporated by reference herein.

[0113] Turning to FIG. 8D, the wings 50 on the guide wire element 16 maybe collapsed back to the collapsed configuration, e.g., by releasing thewings 53 on the actuator region 47 (not shown, see FIGS. 5A and 5B) orthe handle 140 (also not shown, see FIGS. 6A and 6B). Once the wings 50are collapsed, the guide wire element 16 may be withdrawn from thevessel 90.

[0114] Turning to FIG. 8E, the plug member 12 may be deployed from thehandle device 14, and the handle device 14 withdrawn from the passage92. As explained above with respect to FIGS. 4A-4D, the handle device 14may include inner and outer members 80, 70 that may be used to securethe plug member 12 to the handle device 14. When it is desired to deploythe plug member 12, the inner member 80 may be advanced distallyrelative to the outer member 70. This action may also compress thecollet 60 located within the plug member 12, thereby substantiallysealing the lumen 24 through the plug member 12. Finally, furtheradvancement of the inner member 80 may advance the plug member off ofthe outer member 70, thereby releasing the plug member from the handledevice 14.

[0115] Turning to FIGS. 9A and 9B another embodiment of a guide wireelement 116 is shown that may be used with an apparatus to deliver aplug member 12 (not shown), in accordance with the present invention.The guide wire element 116 generally includes an elongated flexible orsemi-rigid body defining a longitudinal axis 117 extending between aproximal end 118 and a distal end 120 thereof. Optionally, the guidewire element 116 may be tubular, e.g., including a bleed back lumen (notextending) extending between the proximal and distal ends 118, 120.

[0116] The guide wire element 116 may be formed from a biocompatiblematerial, and preferably is formed at least partially from abioabsorbable material, similar to the plug member 12 described above.More preferably, the guide wire element 116 includes a bioabsorbabledistal portion 122 that may be detached from the remainder of the guidewire element 116. For example, the distal portion 122 may be severablefrom the remainder of the guide wire element 116. Alternatively, theguide wire element 116 may include cooperating connectors (not shown)that may be decoupled to release the distal portion 122.

[0117] The distal end 120 of the guide wire element 116 includes one ormore lateral elements 124 that are biased to extend laterally, andpreferably substantially perpendicular, with respect to the longitudinalaxis 117, as shown in FIG. 9A. In the preferred embodiment shown, thelateral elements 124 are opposing legs or wings that extend away fromone another. Alternatively, any number, e.g., one or more, of such legsor wings may be provided. The lateral elements 124 may be deflected to acollapsed configuration, as shown in FIG. 9B e.g., to reduce a profileof the guide wire element 116 as it is advanced through a passagethrough tissue (not shown).

[0118] Turning to FIGS. 10A-10E, a method for using the guide wireelement 116 to facilitate delivering a plug member 12 is shown. Similarto the methods described above, a passage 92 may be formed during aprocedure that extends through tissue 96, e.g., from a patient's skin 94to a blood vessel 90. Before or after removing an introducer (not shown)positioned through the passage 92, the guide wire element 116 may beadvanced through the passage 92 until the distal end 120 is positionedin the vessel 90. Because the lateral elements 124 are collapsible, asthe guide wire element 116 is advanced within the passage 92, thelateral elements 124 may be deflected towards the collapsedconfiguration, as shown in FIG. 10A. If the guide wire element 116includes a bleed back lumen, as the distal end 120 enters the vessel 90,blood may flow through the bleed back lumen, providing a visualindication that the vessel 90 has been reached.

[0119] Turning to FIG. 10B once the distal end 120 of the guide wireelement 116 enters the vessel 90, the lateral elements 124 may resumetheir expanded configuration. The guide wire element 116 may then bewithdrawn proximally until the lateral elements 124 contact a wall 98 ofthe vessel 90, thereby providing a tactile indication of the location ofthe vessel 90 relative to the patient's skin 94.

[0120] As shown in FIG. 10C, a handle device 14 carrying a plug member12 may be advanced through the passage 92 over the guide wire element116, similar to the previous embodiments. Optionally, the guide wireelement 116 may include visual indicators, similar to the previousembodiments, to facilitate positioning of the plug member 12 relative tothe wall 98 of the vessel 90. Optionally, similar to the previousembodiments, the plug member 12 and/or handle device 14 may include ableed back lumen (not shown) for identifying when the plug member 12 hasentered the vessel 90.

[0121] Once the plug member 12 is positioned at a desired location, theplug member 12 may be deployed from the handle device 14, similar to theprevious embodiments. Unlike the previous embodiments, however, thedistal portion 122 of the guide wire element 116 may remain within thelumen 24 of the plug member 12 as the plug member 12 is deployed. If theplug member 12 includes a collet or other sealing member 60, similar tothat shown in FIGS. 4A-4D, the collet 60 may be compressed as the plugmember 12 is deployed. Thus, as the collet 60 is compressed tosubstantially seal the lumen 24, it may engage the distal portion 122 ofthe guide wire element 116, thereby substantially anchoring the distalportion 122 of the guide wire element 116 to the plug member 12. Inaddition, if the guide wire element 116 includes a bleed back lumen, thecollet 60 may compress the guide wire element 116 to substantially sealthe bleed back lumen.

[0122] In addition, or alternatively, the plug member 12 may includeflanges or other locking elements (not shown) that may slidably engagethe guide wire element 116 as the plug member 12 is advanced over theguide wire element 116. If the plug member is directed proximally, thelocking elements may engage the guide wire element 116 and preventrelative movement of the plug member 12 and guide wire element 116.Optionally, the guide wire element 116 may include ratchet elements (notshown) that may allow the locking elements to over the ratchet elementsin a distal direction, but interlock to prevent movement in a proximaldirection.

[0123] Turning to FIG. 10D, after the plug member 12 is released fromthe handle device 14, the handle device 14 may be withdrawn from thepassage 92, leaving the plug member 12 and the guide wire element 116within the body. Because the distal portion 122 of the guide wireelement 116 is preferably formed from a bioabsorbable material, thedistal portion 122 may be separated from the remainder of the guide wireelement. For example, a cutting device (not shown) may be advanced intothe passage 92 to sever the distal portion 122, whereupon the remainderof the guide wire element 116 may be withdrawn from the passage 92.Alternatively, if the guide wire element 116 includes cooperatingconnectors (not shown), the connectors may be decoupled to release thedistal portion 122.

[0124] Thus, the plug member 12, as well as the distal portion 122 ofthe guide wire element 116 may remain within the passage 92. The plugmember 12 may substantially seal and/or close the passage 92, as seen inFIG. 10E, and secure the distal portion 122 of the guide wire element116 from separating from the plug member 12. As the tissue 96surrounding the passage 92 heals, the distal end 318 of the guide wireelement 316 and/or the plug member 12 may be absorbed by the body.

[0125] While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the spiritand scope of the appended claims.

What is claimed is:
 1. A guide wire device for facilitating positioninga closure device within a passage through tissue, comprising: anelongate outer wire element comprising proximal and distal ends defininga longitudinal axis therebetween, an expandable positioning elementadjacent the distal end, an expandable actuator element adjacent theproximal end, and an intermediate region extending between thepositioning and actuator elements; and an elongate inner wire elementcomprising proximal and distal ends that are fixed relative to theproximal and distal ends of the outer wire element, and wherein theintermediate region of the outer wire element is movable axiallyrelative to the inner wire element for expanding and collapsing thepositioning and actuator elements.
 2. The guide wire device of claim 1,wherein the outer wire element comprises a first configuration in whichthe positioning element is collapsed and the actuator element isexpanded, and wherein the actuator element is compressible inwardly,thereby expanding the positioning element radially outwardly anddefining a second configuration.
 3. The guide wire device of claim 2,wherein the positioning element comprises one or more wings extendingsubstantially parallel to the longitudinal axis in the firstconfiguration, and wherein the actuator element is compressible forcausing the intermediate region of the outer wire element to movedistally, thereby buckling the one or more wings to expand the one ormore wings radially outwardly in the second configuration.
 4. The guidewire device of claim 3, wherein the one or more wings are biased towardsthe first configuration.
 5. The guide wire device of claim 1, whereinthe outer wire element comprises a visual marker on the proximal endthereof, the marker being located a predetermined distance from the oneor more positioning elements.
 6. The guide wire device of claim 1,wherein the outer wire element has a substantially uniform cross-sectiondistal to the actuator element in the first configuration.
 7. The guidewire device of claim 6, wherein the outer wire element has a diameter ofnot more than about 0.5-2.0 millimeters in the first configuration.
 8. Aguide wire device for facilitating positioning a closure device within apassage through tissue, comprising: an elongate outer wire elementcomprising proximal and distal ends defining a longitudinal axistherebetween, and one or more positioning elements adjacent the distalend, the one or more positioning elements extending substantiallyparallel to the longitudinal axis to define a collapsed configuration;an elongate inner wire element comprising proximal and distal ends, thedistal end being fixed relative to the distal end of the outer wireelement; a handle coupled to the proximal end of the inner wire elementfor directing the inner wire element proximally relative to the outerwire element, thereby causing the one or more positioning elements toexpand radially outwardly towards an expanded configuration; and aspring element coupled between the proximal ends of the inner and outerwire elements for biasing the one or more positioning elements towardsthe collapsed configuration.
 9. The guide wire device of claim 8,wherein the outer wire element comprises a visual marker on the proximalend thereof, the marker being located a predetermined distance from theone or more positioning elements.
 10. An apparatus for sealing a passagethrough tissue in a body, comprising: an elongate delivery devicecomprising a lumen extending between proximal and distal ends thereof,and defining a longitudinal axis; a plug member detachably carried bythe distal end of the delivery device and comprising a lumencommunicating with the lumen of the delivery device; and a guide wireelement comprising a proximal end receivable through the lumens in theplug member and the delivery device, the guide wire element comprisingone or more lateral elements on a distal end thereof.
 11. The apparatusof claim 10, wherein the guide wire element comprises a visual marker onthe proximal end thereof, the marker being located a predetermineddistance from the one or more lateral elements, the predetermineddistance corresponding to a length of the delivery device and the plugmember carried thereby for providing a visual indication of the relativelocation of the one or more lateral elements and the distal end of theplug member when the visual marker is visible beyond the proximal end ofthe delivery device.
 12. The apparatus of claim 11, wherein the guidewire element comprises a plurality of visual markers spaced apartaxially from one another on the proximal end thereof.
 13. The apparatusof claim 10, wherein the lateral elements comprise one or moreexpandable wings, the one or more expandable wings being actuable fromthe proximal end of the guide wire element for selectively expanding andcollapsing the wings.
 14. The apparatus of claim 13, wherein the guidewire element comprises: an elongate outer wire comprising proximal anddistal ends, the one or more wings being disposed adjacent the distalend and extending substantially parallel to the longitudinal axis in afirst configuration; and an elongate inner wire comprising proximal anddistal ends, the distal end being fixed relative to the distal end ofthe outer wire, wherein the inner wire is movable axially relative to anintermediate region of the outer wire for expanding the one or morewings from the first configuration towards a second configuration. 15.The apparatus of claim 14, wherein the proximal end of the inner wire isfixed relative to the proximal end of the outer wire, the proximal endof the outer wire comprising one or more actuator elements adjacent theproximal end that are expanded in the first configuration, the one ormore actuator elements being compressible inwardly, thereby expandingthe one or more wings radially outwardly and defining the secondconfiguration.
 16. The apparatus of claim 14, further comprising ahandle coupled to the proximal end of the inner wire for directing theinner wire proximally relative to the outer wire, thereby causing theone or more wings to expand radially outwardly towards the secondconfiguration.
 17. The apparatus of claim 16, further comprising aspring element coupled between the proximal ends of the inner and outerwires for biasing the one or more wings the first configuration.
 18. Theapparatus of claim 10, wherein the plug member further comprises asealing member slidably disposed within the lumen of the plug member,the sealing member comprising a plurality of shoulders disposed about alumen of the sealing member, the shoulders being deflectable towards oneanother for at least partially sealing the lumen of the sealing member.19. The apparatus of claim 18, wherein the sealing member is movableinto a reduced cross-sectional region of the lumen in the plug memberfor deflecting the shoulders towards one another to at least partiallyseal the lumen in the plug member.
 20. The apparatus of claim 10,wherein a distal portion of the guide wire element is detachable from aproximal portion thereof, the distal portion being disposed at leastpartially within the plug member.
 21. The apparatus of claim 20, whereinat least one of the plug member and the guide wire element arebioabsorbable.
 22. The apparatus of claim 20, wherein the distal portionis securable to the plug member.
 23. A method for sealing a passagethrough tissue from a patient's skin to a body lumen, comprising:advancing a distal end of a guide wire element from the patient's skinthrough the passage and into the body lumen; expanding one or morelateral elements on the distal end of the guide wire element; partiallywithdrawing the guide wire element from the body lumen until the one ormore lateral elements contact a wall of the body lumen; inserting aproximal end of the guide wire element into a lumen of a plug member,the plug member comprising a sealing member therein at least partiallysurrounding the guide wire element; advancing the plug member into thepassage over the guide wire element; directing the sealing member into areduced cross-sectional region of the lumen, thereby at least partiallysealing the lumen; and withdrawing at least a portion of the guide wireelement from the passage.
 24. The method of claim 23, wherein the plugmember comprises an external thread pattern, and wherein the plug memberis advanced by rotating the plug member, thereby threading the plugmember through the passage.
 25. The method of claim 23, wherein the plugmember is advanced into the passage until the plug member is disposedadjacent to the one or more lateral elements.
 26. The method of claim23, wherein the step of withdrawing at least a portion of the guide wireelement from the passage comprises collapsing the one or more lateralelements, and withdrawing the guide wire element from the passage. 27.The method of claim 23, wherein the plug member is carried on a distalend of a delivery device comprising a lumen communicating with the lumenin the plug member and through which the guide wire element is directed,and wherein the method further comprises releasing the plug member fromthe distal end of the delivery device after the plug member is advancedinto the passage.
 28. The method of claim 27, wherein the guide wireelement comprises a marker on a proximal portion thereof that is locateda predetermined distance from the one or more lateral elements, andwherein the plug member is released from the delivery device when themarker appears from a proximal end of the delivery device, therebydeploying the plug member adjacent to the one or more lateral elements.29. The method of claim 27, wherein the plug member is released from thedelivery device when the plug member contacts the one or more lateralelements.
 30. The method of claim 27, wherein the guide wire elementcomprises a marker on a proximal portion thereof that is located apredetermined distance from the one or more lateral elements, andwherein the step of advancing the plug member is discontinued when themarker appears from a proximal end of the delivery device.